Jerri-Lynn here: This Real News Network interview with former Brazilian Minister of Foreign Relations Celso Amorim discusses the crucial problem of which priorities should prevail when intellectual property protection collides with public health concerns. The interview is admittedly rather dense, but it is not inscrutable, so I encourage readers to persevere. In the latter part of the interview, Amorim discusses the role of public financing of research into areas that are public health priorities, so as best to develop necessary medicines and treatments, and the need to delink these efforts from concerns over intellectual property protection.

Celso Amorim served as Brazil’s Minister of Foreign Relations under President Itamar Franco (1993-1994), and again under President Luiz Inacio Lula da Silva (2003-2010), and as Minister of Defence under President Dilma Rousseff (2011-2014). Amorim is the longest serving foreign minister of Brazil to date. Currently, Ambassador Amorim is the Chair of UNITAID, Board Member of the Advisory Council of Salamanca University, Chief of the Organization of American Sates’ mission of Electoral Observation in Haiti, and member of the UN Secretary General’s High-Level Panel on Access to Medicines. In 2015, he was a member of the UN Secretary General’s High Level Panel on the Global Response to Health Crises.

LYNN FRIES: Welcome to The Real News Network. I’m Lynn Fries, in Geneva.
In this brief, we look into the recent Geneva visit of legendary Brazilian Ambassador Celso Amorim.

We report on his discussions at the World Trade Organization, and at The Real News, as Ambassador Amorim talks about the UN Secretary General’s High-Level Panel on Access to Medicines.

Whether it’s the rising price of the EpiPen, or new outbreaks of diseases, like Ebola or Zika, yellow fever; the rising costs of health technologies; and the lack of new tools to tackle health problems, like antimicrobial resistance - is a problem in rich and poor countries alike. So states the report of the UN High-Level Panel on Access to Medicines.

In keeping with the Panel’s mandate, the report’s recommendations are for remedying incoherence between policies and agreements related to human rights, trade, intellectual property rights, and public health, that were developed with different objectives at different times.

And incoherence seen as international trade rules, with intellectual property laws, that were developed to promote economic growth and incentivize innovation, can impede nations from fulfilling state obligations, not only to respect, but to protect and fulfill the right to health.

In short, a misalignment between profit-driven innovation models and public health priorities; a misalignment that allows medicine to be priced out of reach of patients and governments alike.

As issues around public health, intellectual property, and trade, straddle many different UN organizations, discussions of the Panel’s report reach into many different forums here in Geneva.

We feature a discussion hosted at the World Trade Organization, as WTO member states were invited to discuss the report with some members of the High-Level Panel and their expert advisors.

The event was organized by the South Center, together with the UN Secretariat of the High- Level Panel on Access to Medicines, and co-sponsored by the governments of Bangladesh, Brazil, India and South Africa.

We focus on the narrative explained by Panel member, Ambassador Celso Amorim.

The legendary ambassador is Brazil’s longest-serving Minister of Foreign Relations. Ambassador Amorim’s former posts include his service as Brazil’s Minister of Defence and as Ambassador to the UN.

Acting Globally, Celso Amorim’s latest book, is a book of his memoirs; one of three narratives is Brazil’s leading role in the Doha Round of multilateral trade negotiations. Celso Amorim’s leading role in these historic negotiations is central to his current role as Chairman of UNITAID, and member of the UN High-Level Panel on Access to Medicines.

This was explained by Ambassador Amorim, at the recent WTO event featured in this report. We go now to clips of that event as Ambassador Amorim is given the floor.

CELSO AMORIM: It’s a very complex report. I will just concentrate on one aspect, which was the one aspect that I thought I could  I would not say make a difference  but at least have some knowledge; which is the question of TRIPS flexibilities, and TRIPS plus provisions, to some extent.

And there, for good reason, I was… well, of course, this room is totally new to me, but I was Ambassador here to the old GATT, when the TRIPS Agreement was accepted.

I had great reluctance in accepting it, and must say that the Brazilian Congress had great reluctance in accepting it, because it imposed many restrictions on our capacity of industrializing ourselves, and not only limited to the pharmaceutical field.
But in the end, we thought we could not stay out of the world, and so we did see…

I still remember  just trying to be very brief  I still remember when the end of the discussion on the TRIPS group came out.

It was headed by a Swedish ambassador, Lars Anell, and I had an advisor, who’s now ambassador somewhere, I don’t know, Mr. Pirajibi, and I remember how disappointed and discouraged we were.

And I had to point out to him, Well, Mr. Pirajibi, we still have some ambiguities. Maybe we will be able to work on them. And he told me, Well, but we’ll lose. Wherever it comes, ambiguity, the stronger we will show their force, and we’ll lose.

Well, but of course, as it happens in the world, the evolution of the society, and the problems - and especially I would say HIV/AIDS, and the forces that were unleashed by the epidemics of HIV/AIDS - changed a little bit the political situation.

When the Uruguay Round was launched - and I signed the Uruguay Round so I’m not speaking against it necessarily - so when the Uruguay Round was launched, it was really for the globalization of capitalism; to make sure that there would be no restrictions to profit and to the work of the multinational companies.

But, of course, in a multilateral setting, there are always discussions, we could, here and there - and I won’t go into the technical detail because Mr. Correa knows much more than I do - but we were able here and there to put some provisos; some, oh, well, maybe these would be them.

And what happened because of this evolution that I mentioned; especially the last decade of the 20th century, because of HIV/AIDS?
The political situation in the world to some extent changed. We have… we felt that directly, because Brazil was brought to court, so to say, by the United States, concerning our patent law. And in the end they had to give up, because they saw that it was not so easy.

And somehow, those ambiguities - probably the biggest step forward - the Doha Declaration means these ambiguities became flexibilities.

So they were accepted as established flexibilities. They were no longer ambiguities, so they could no longer be used against us; against developing countries; against countries with the need - or other countries, for that matter - but in that case, mainly developing countries.

And that’s what we have in the Doha Declaration. All of you are familiar with the Doha Declaration, but I think it’s useful to remind you of one specific paragraph, which is Paragraph 4. I won’t mention Paragraph 6, which is still some polemics.

But Paragraph 4 says, “We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect  that’s very important  it does not and should not  so it’s both the factual and the prescriptive  should not prevent members from taking measures to protect public health. Accordingly, while reiterating the commitment to the TRIPS Agreement, we affirm that the Agreement can and should  again, the existence and the prescription  can and should be interpreted and implemented in a manner supportive of WTO members’ rights to protect public health, and in particular to promote access to medicines to all.”

So, really, I think this is the core  of course, Paragraph 6 is important for the countries that do not have the capacity to produce. It is another matter. But in any case, this is the core of the Declaration.

So I found that my main role was to recall that - because there were, of course, many good ideas to improve on the language.
But I have seen many times, whenever we try to improve on the language, in the end we lose what we have got.

And that was a very specific situation I have to tell you that we’d got; not only because we had this very strong lobby of people infected with HIV/AIDS, or the community that was preoccupied with HIV/AIDS; but there was also another factor, which was September 11th.

The United States needed desperately to have the launching of the Doha Round, in order to avoid the accumulation of the economic crisis.

And this is why these things, which appear to be the most difficult, were the first to be accepted in Doha. I negotiated that personally, so I know more or less the meaning of each word and why it is there.

And in the end of the negotiation … because what we got here was somehow an exemption from trade retaliations within the WTO. We couldn’t get more than that. That was the main objective.

And that’s why, I think, you’ll see if you read the object, the Goal Number 3 of the SDGs or other declarations, and several far off people agreeing. But when it comes to trade, then they abandon that. And they use… if they cannot bring to retaliate in the WTO, they use bilateral and pluri-lateral agreements.

I think it has to be the crucial point for countries that have tried to do  I don’t want to mention the name of countries here, but we know that, in South East Asia and in South America, countries suffered quite a lot of pressure from the laboratories and from governments, including that went much beyond trade … not to apply compulsory license or not to apply other TRIPS flexibilities.

So that’s why I want to mention that in my opinion, the most important  and the language is very strong  the most important paragraph in the recommendations of the High-Level Panel, is in 2.6 of the recommendations that relate to IP, the Chapeau actually, when it says, “World Trade Organization  WTO  members should commit themselves at the highest political level  so that would not be anyone, not just a Trade Minister, not the delegate in the Human Rights Council, but the highest political level - to respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technology.”

What I’m saying now may sound… it could be a token anyway to some extent, but we have to fight for a token, that’s the role that we have.

It sounds even more a token now, because I just read a document - which I don’t know if it was approved yet - which was to be the National Trade Policy of the biggest power… the two biggest trading powers in the world, in which, among other things, it is said that they should ensure U.S. owners of intellectual property have a full and fair opportunity to use and profit from the property.

They should resist efforts  by other countries, or international bodies like the WTO, to weaken these rights and benefits, and furthermore to use all possible sources of leverage  all possible sources of leverage  all sources  that includes military force? I don’t know  all… all sources of leverage to encourage other countries to open their markets to universal exports of goods and services, and protect U.S. intellectual property rights.

In the case of health, governments that signed the World Trade Organization Multilateral Agreement on Intellectual Property, the TRIPS Agreement, can use TRIPS’ flexibilities to act in the public interest.

The use of these TRIPS flexibilities by governments can be impeded, for example, by other free trade agreements, most notably ones with TRIPS-Plus provisions.

Let’s pick up the conversation from there.

CELSO AMORIM: Well, of course, the question of access to medicine has several dimensions. But one of them has to do with intellectual property and the patent systems.

In the WTO, we were able to evolve some rules; first in the TRIPS Agreement - Trade-Related Intellectual Property Rights Agreement - when the WTO was created.

But as things evolved and new realities appeared, including the HIV/AIDS and many others, we were able to have a clarification of the TRIPS Agreement when we had the Doha Declaration on TRIPS and Public Health; which is extremely important, and which really makes it clear the flexibilities that countries, governments, have to deal with public health in relation to patent rights.
And now what happened recently in relation to this subject?

Well, the countries that have the biggest interest in intellectual property protection - which is right; we are not against intellectual property protection, but they want to see that health prevails when there is a conflict - they tried to work either on bilateral agreements, or in what you might call pluri-lateral agreements, of the kind of what was the TPP.

LYNN FRIES: In the context of trade negotiations, can you clarify what multilateral means?

CELSO AMORIM: That’s a very interesting question, because at least from my point of view, we see a lot of confusion, even in the U.S., when people discuss now the policies of the present president, quite irrespective of the value judgments.

They say, well, they are withdrawing from the multilateral setting. And they - I think - when they refer, for instance, to the TPP - the TPP, the Trans-Pacific Partnership, is not multilateral. It’s a regional thing. It’s not the whole world. So it’s a group of countries irrespective of the limits that they might see or not see.

Like NAFTA is not multilateral. It’s a different thing that you have to deal separately.

The real multilateral body in terms of trade is the WTO. And we favor very much  you asked - the multilateral setting, so the broad setting, the world setting. Not just the regional, or that a group of countries for these negotiations that involve aspects that actually go beyond trade, because we are speaking of the lives of people and the possibility of using generic drugs which are much cheaper.

LYNN FRIES: It was through multilateral negotiation that you got TRIPS flexibilities. Talk of some of the ways these flexibilities have made a difference in people’s lives.

CELSO AMORIM: In developing countries, yes, I mean, there the flexibility that enables us to have a medicament for HIV/AIDS or for TB or for other even cancer, or high blood pressure or whatever - at a much lower price than is charged in the market. So that flexibility is enshrined in the Doha Declaration.

Now coming back to the Panel. We do recognize, of course, that the laboratories have to be compensated for, for the research they do. By the way, much of the research is not them. Much of the research is done by public funds, anyway. But, anyway, if they do, they have to be compensated for it. It’s a private business. But we think it has to be done in a different way.

LYNN FRIES: Before talking about doing things in a different way, talk about the prevailing way of doing things, based on profit-driven innovation models with international enforcement mechanisms.

CELSO AMORIM: It’s very… I mean, even the developed countries it’s relatively  not easy, nothing is easy  but it’s accepted that if you have funding, for instance, for a new weapon it’s not much discussed.

But if you have public funding for a medicine or for public services, then there is a lot of opposition. So, because this is the political reality, they try to recoup the investment through the intellectual property, both domestically and globally.

And I think some of the big challenges that we are facing nowadays  not only developing countries, but even in the developed world, like the antimicrobial resistance, for instance - the level of investment is so big that you won’t be able to recoup through patents anyway, so we have to think of a different model.

LYNN FRIES: Comment on your work with UNITAID as an example of the need for a new model, even when levels of investment are not so big.

CELSO AMORIM: Yeah. I am the chairman of the board of a small organization, but which acts very specifically in some, what might be called some market failures, in terms of having medicines for certain diseases, or for certain groups of populations.

For instance, children - pediatric formulations for treating HIV/AIDS. That is not of interest in the developed countries anymore because it doesn’t happen so often. So there is no market for that. So my very active and dynamic organization acts in these kinds of things, quick testing for TB, things like that.

I think when we come to the High Level Panel, it deals with the whole model of how intellectual property, or the innovations, should be dealt with.

And I think that this whole idea of delinkage, of separating the idea of how you finance the research from the price of medicines, is really an essential and that…

And I mentioned to you in relation to antimicrobial resistance - but it applies to many other things, even to non-communicable diseases, also, like cancer and others - how to make the medicines affordable and still continue with doing research.

Well, I don’t see any other way from public financing. Either it’s national or international, or a mixture of both, depending on the situation of the country.

Of course, if you take a small country like - I don’t know  Malawi or whatever, it will depend a lot on international. In the United States it could be basically national. In Brazil it probably will be a mixture.

But, anyway, it has to be public financing that does the bulk of it. And then maybe, of course, I don’t know, in some cases that are very specific, you can also still have the patent protection.

But certainly in areas that have great impact on public health, delinkage is very important.

So, again, what I wanted to stress - because that’s the situation we face today. This is there, it’s a fact of life, it will be very difficult to change, it will take a long time. I mean, if you want to apply this concept of delinkage, some countries may apply, some others will not apply.

But we have a defense, at least, a protection, to avoid abuses, and this protection is encapsulated in the Doha Declaration of TRIPS and Public Health.

So, that’s what we want to save, and that’s why all these agreements, which are TRIPS-Plus, they are so negative but… public authority… they have to treat health the way they treat defense.

I mean, nobody asks to get the money in the market for a new weapon; so the weapon to save lives has to be treated the same way people have the military: it is the public authority that somehow has to finance. Of course, it’s money from the taxpayer, but they will have to pay much more later on with the diseases, with death and so on if they don’t do that.

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Shire CEO Angus Russell in May 2011 (just months prior to his retirement) said, “Prices were just shoved up every year to make more money and meet earnings, to be blunt.” He was referring to mass marketed drugs used to treat common conditions–like diabetes.

Antithetical to what “free market” supply/demand curves are supposed to create, the price of insulin has skyrocketed as the numbers of insulin requiring type II diabetics soar.

Insulin is the grandfather of all biologics, approved by the FDA as the first genetically – engineered drug product in 1982. American company Eli Lilli manufactured human insulin, trademarked as Humulin. U.S. drug manufacturers discontinued pork insulin (the remaining animal – sourced insulin ) in 2006 even though a comparison of the effects and the adverse reaction profile of human and animal insulin did not show clinically relevant difference.

E Coli and yeast are the factories that crank out “human” insulin and analogs that are tweaked to create drugs peaking earlier or later and lasting shorter or longer times. A quicker acting insulin is used when eating and longer lasting “peakless” insulins allow basal delivery of the drug.
See: http://www.webmd.com/diabetes/guide/diabetes-types-insulin#1

The family of a little girl with Type I DM can’t afford the $250 per vial co-pay for the Sanofi rapid onset insulin analog, glulisine. (When I practiced two decades ago, insulin cost ~$10 per vial.) Her family turns to the underground market because their daughter suffers from allergic reactions to the cheaper drug available. (One might wonder how she would fare with porcine insulin. See: https://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm173909.htm#Q-1)

The big three insulin manufacturers (Eli Lilly and Company, Novo Nordisk, and Sanofi-Aventis) have found their niches to monopolize the international market, but especially so in the U.S. That’s partly because the FDA has been slow on the go in approving “biosimilars”–the quasi generics of these drugs. See: http://www.medscape.com/viewarticle/859534_3

US negotiators didn’t like the IP chapter of the TPP negotiations when it came to biologics. It’s provisions would have lowered data exclusivity for this category of drugs from 12 to 5 years (at minimum, that is). Obamacare had already enshrined those patent protection and would continue to do so in the U.S.–whether or not the TPP was approved by Congress.

In December 2015, the FDA approved Basaglar as the first “follow-on” insulin glargine product to treat diabetes through an “abbreviated approval pathway.” The FDA went to great pains to say, “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no ‘reference product’ for a proposed biosimilar product.” (Note: Wikipedia says biosimilars are also known as follow-on biologic or subsequent entry biologic.)

Now Lilly/Boehringer Ingelheim can “compete” with Sanofi’s wildly successful basal Lantus (insulin glargine). The GoodRx Fair Price for Basaglar is $328 and for Lantus is $385.

It isn’t just insulin. Allergies are a much bigger problem in the supply chain than is acknowledged.

After being poisoned by dental mercury, I developed sensitivities to everything possible. I once checked through all the ingredients for claritin and similar drugs and they all had dyes and fillers that made me very sick (e.g., maltodextrin, rice, sorbitol…). I had to get my allergy pills specially compounded because I was allergic to all the commercially available allergy pills.

Only in America, right?

Many of these ingredients are added purely to “improve” the taste or give the drug a marketing image (“the little blue pill”). Nobody in marketing thinks, “This could actually kill somebody.” They just don’t care. They want a cute logo on the pill to match the box.

The FDA is in the process of changing compounding so that pharmacies can’t order the raw ingredient to reconstitute it in a form that’s actually safe for allergy sufferers. They expect them to order the pill and then somehow extract the active ingredient.

oldie but goodie link ref – in the latter part of the interview, Amorim discusses the role of public financing of research into areas that are public health priorities, so as best to develop necessary medicines and treatments, and the need to delink these efforts from concerns over intellectual property protection.

Prescription Drug Prices Are Out Of Control. Bernie Sanders Has A Plan.

Sanders’ proposal says, “Congress should uncouple research and development costs from drug prices by rewarding innovation with a prize.” That’s an idea that’s been discussed by economists Dean Baker and Joseph Stiglitz as a way for the government to reward the development of successful new drugs by buying the patents and letting the drugs be sold as generics immediately.

This is an enclosure fight, as the comment about n insulin shows. Insulin is a public domain chemical, so TRIPS should never come up and yet price-fixing cartels are jacking up prices because they’ve managed to shove publically owned chemicals out of the way through regulators or by creating shortages/price bottlenecks via the legalized cartel kickback system called Pharmacy Benefit Managers.

There are, in fact, plenty of cheap solutions to these problems. Let compounding pharmacies reconstitute epinephrine from powder into vials/syringes like the could pre-2004 and your $600 EpiPen drops to $2. There are similarly cheap approaches to chronic pain, autoimmunity, cancer and diabetes.

Very few questions at the oral argument focused on the two most general aspects of the case: (i) the long-running policy war over the optimal level of patent protection for medicines, and (ii) the complex technology of biologics and biosimilars. The dearth of questions on those matters is to be expected. The justices clearly understood that, in enacting the relevant statute, Congress was trying to strike a balance between patent protection and access to medicines, and that the underlying complexities of the technology partly explain why the statute is so complex. The justices were instead devoting almost all of their attention to trying to discern what balance had been struck by Congress.

It is a well-known story that Big Pharma aggressively uses trade negotiations, political lobbying, and domestic and international litigation (and the threat thereof) to expand the monopoly rents it gains from patent protection, and defeat the effort of states to limit intellectual property rights in the public interest, whether through compulsory licensing, or other means. There was understandable cheering at the recent news that Eli Lilly’s lost its ISDS case against Canada, challenging the Canadian courts’ reading of Canada’s own patent laws as an “expropriation” (among other violations of NAFTA).
A close reading of the case, however, shows that the ruling is in fact extremely dangerous for the public interest

Incredibly, the Eli Lilly tribunal managed to decide the case without articulating any legal standard at all for the meaning of “expropriation” under NAFTA. The tribunal left the door open for “regulatory takings” arguments that, even where entirely legitimate and publicly interested, changes to regulation nevertheless have to be compensated by the host state merely because they have an economic effect equivalent to a direct taking (Metalclad).

So what is the real message of the Eli Lilly tribunal? They are not coming out and saying it, but they encourage future regulatory takings claims by implication that the concept of “expropriation” under NAFTA might well apply to require a host state compensate an investor even for jurisprudential shifts in the approach of a country’s highest courts to that country’s law (including its constitution), if that shift can be characterized as dramatic, radical, or fundamental.
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TRIPS Flexibilities Under Threat From Investment Disputes: A Closer Look At Canada’s “Win” Against Eli Lilly

Why is Canada’s “win” troubling? It is true that Eli Lilly ultimately failed to persuade the investment tribunal that Canada’s invalidation of two patents, based on its interpretation of “useful,” compromised guarantees under NAFTA’s investment chapter. But, it should be noted, this failure was principally evidentiary in nature. That is, Eli Lilly failed to provide adequate evidence in support of its claims, all of which were premised on its assumption that there was a dramatic change in the law. The tribunal, however, never questioned whether IP rights that were invalidated consistent with domestic law could constitute a violation of international investment law. Even more importantly, the tribunal never questioned whether patent laws consistent with TRIPS could nonetheless be challenged as compromising investment agreements.
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LINK ref what the MNCs are engineering

Regime Shifting of IP Law Making and Enforcement from the WTO to the International Investment Regime

This article provides new insight to regime shifting and regime complexes through one of the first detailed analysis of the regime shift in intellectual property law making and enforcement from the World Trade Organization to international investment law. Unlike prior cases of regime shifting that have predominantly focused on the efforts of States and NGOs creating counter-norms viz-a-viz those of the WTO’s TRIPS Agreement, the current regime shift is primarily engineered by multinational corporations seeking to destabilize TRIPS flexibilities through investor-state arbitration. Since defending these cases costs countries millions of dollars, this regime shift to investor state arbitration has a significant chilling effect on the regulatory authority of states. We argue and show that by bringing or threatening to bring investor-state litigation to protect their IP rights against countries seeking to protect public health, pharmaceutical and tobacco companies pose a serious threat to the sovereignty of countries to implement the TRIPS Agreement in a manner that balances IP rights against values such as access to affordable medicine. As a consequence this Article argues that this regime shift is significant not only for developing countries, but for developed countries, such as Canada, Australia, and members of the European Union as well.